Evaluation of the effect of adipose tissue-derived stromal vascular fraction cells (SVF) and nanofat for the maintenance and improvement of autologous fibroblast function in facial rejuvenation
Evaluation of the effect of adipose tissue-derived stromal vascular fraction cells (SVF) and nanofat for the maintenance and improvement of autologous fibroblast function in facial rejuvenation
Design
Clinical trial with a control group and an intervention group, with parallel groups, systematic randomizationو one sided blind, phase 1 on 10 patients with Mild to moderate wrinkles
Settings and conduct
This project is carried out in the Skin and Stem Cell Research Center of Tehran University of Medical Sciences. One group is treated with nanofat and SVF cells and autologous fibroblasts by injection, and the other group is treated with nanofat and autologous fibroblasts by injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20-60; Having Mild to moderate wrinkles on the face. Exclusion criteria: Pregnancy and breastfeeding; Active infection in face; Using any injectable fillers on the face in the last six months
Intervention groups
Intervention group: They receive 5 cc of nanofat product along with 10 million fibroblast cells and 10 million autologous SVF cells. Control group: They receive 5 cc of nanofat product along with 10 million autologous fibroblast cells.
Main outcome variables
The amount of wrinkles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N30
Registration date:2023-05-09, 1402/02/19
Registration timing:registered_while_recruiting
Last update:2023-05-09, 1402/02/19
Update count:0
Registration date
2023-05-09, 1402/02/19
Registrant information
Name
Sona Zare
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 7438
Email address
sonazarebio@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-07-11, 1402/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of adipose tissue-derived stromal vascular fraction cells (SVF) and nanofat for the maintenance and improvement of autologous fibroblast function in facial rejuvenation
Public title
Evaluation of the effect of SVF cells and nanofat for autologous fibroblast function in facial rejuvenation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-60
Having middle to moderate wrinkles
Exclusion criteria:
Pregnancy and breastfeeding
History of cancer
Patients with a new history of gel and Botox injections
People with Mental Disorders
Active infection in the face
Age
From 20 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
Data analyser
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Considering that the number of cases in this research plan is 10 people, and both sides of the face are randomly divided into two parts, therefore, the randomization method in this research plan will be done in such a way that the faces of the patients will be randomly selected using systematic randomization method and The numbers generated by the computer will be divided into two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst will not be given information about the grouping and will be named A and B groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1937957511
Approval date
2022-11-26, 1401/09/05
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.609
Health conditions studied
1
Description of health condition studied
Skin aging
ICD-10 code
L90.9
ICD-10 code description
Atrophic disorder of skin
Primary outcomes
1
Description
The amount of wrinkles
Timepoint
Before treatment and six month after the last session
Method of measurement
Visio face
Secondary outcomes
1
Description
Inflammation
Timepoint
After each session
Method of measurement
Questionnaire and visit
2
Description
Intensity of pain
Timepoint
Treatment time
Method of measurement
Questionnaire and visit
Intervention groups
1
Description
Intervention group: They receive 5 cc of nanofat product along with 10 million fibroblast cells and 10 million autologous SVF cells.
Category
Treatment - Other
2
Description
Control group: They receive 5 cc of nanofat product along with 10 million autologous fibroblast cells.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No. 4, Maryam Alley, South Kamraniye St.
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
Dr_nilforoush@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotuhi
Street address
Floor 6th vice president of research and technology, Central University Organization, Corner of Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 81631
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No. 4, Maryam Alley, South Kamraniye St.
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
No. 4, Maryam Alley, South Kamraniye St.
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
Dr_nilforoush@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No. 4, Maryam Alley, South Kamraniye St.
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available